MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92128

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hematoma (1884); Unspecified Infection (1930)

Event Date 08/22/2018

Event Type  Injury  

Manufacturer Narrative

This report is submitted on august 22, 2018, (b)(4).

Event Description

Per the clinic, the patient sustained a head trauma and subsequently developed an infection and eventually a hematoma at the abutment site.Revision surgery has been planned to place a healing cap over the site and treat the infection, however, this has not yet occurred as of the date of this report.

Manufacturer Narrative

It was reported that the patient was administered a topical steroid and a dressing and a healing cap was placed on (b)(6) 2018.

• Brand Name: BI300 IMPLANT 3MM
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 43533 ; SW 43533
• Manufacturer Contact: sujeewa wijesinghe ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7803720
• MDR Text Key: 117828489
• Report Number: 6000034-2018-01729
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502019538
• UDI-Public: (01)09321502019538(10)COH888447(17)210420
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 92128
• Device Catalogue Number: 92128
• Device Lot Number: COH888447
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2018
• Initial Date FDA Received: 08/21/2018
• Supplement Dates Manufacturer Received: 08/23/2018
• Supplement Dates FDA Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR